SHENZHEN, CHINA – China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on September 24, 2024, the New Drug Application (NDA) for vitiligo indication of ruxolitinib phosphate cream (the “ruxolitinib cream” or the “Product”) has been accepted by the National Medical Products Administration of China (NMPA). This is another substantial milestone for ruxolitinib cream in China, following the approval for Urgent Clinical Import by Hainan Medical Products Administration and approval for marketing in Macau for vitiligo, and it is also a key step in benefiting over ten million of patients with vitiligo in China.

Ruxolitinib cream achieved positive results in Chinese Real-World Study. The primary efficacy endpoint was the proportion of patients in the treatment group who achieved F-VASI 75 response at week 24, which was 49.5%, significantly higher than the target value of 14.1% (p<0.0001). The study met its primary endpoint, demonstrating that ruxolitinib cream is effective in treating patients with nonsegmental vitiligo, reducing the area of the lesions, and repigmenting the skin. All secondary efficacy endpoints showed a trend of benefit consistent with the primary efficacy endpoint, and the treatment effect for vitiligo continued to improve with longer treatment duration. Adverse events mostly had severity levels of grade 1 or 2. No adverse event (AE) leading to discontinuation or withdrawal, and no serious adverse event (SAE) related to the study drug occurred.

While advancing the process of NDA for the Product, the Group is conducting the transfer of ruxolitinib cream from overseas production to domestic production (localization technology transfer), which is being orderly promoted by the Contract Development Manufacturing Outsourcing Organization (CDMO), and the lab-scale and pilot trial studies have been completed and under scale-up production. The Group strives to complete the localization study as soon as possible, register in Mainland China and obtain marketing approval, so as to enable the Chinese patients with vitiligo to use the innovative product.

Vitiligo is a chronic autoimmune disease characterized by depigmentation of the skin, which results from the loss of pigment-producing cells known as melanocytes. It is estimated that there are approximately 14 million vitiligo patients in China^[1]. Non-segmental vitiligo patients account for approximately 85% of them. Topical corticosteroids (TCS) and calcineurin inhibitors (CI) are used off-label for non-segmental vitiligo, however, these therapies have clinical deficiencies with long-term adverse reactions of long-term treatment or limited efficacy^[2、3]. If the Product being successfully approved for marketing in China, it will be the first prescription drug approved for repigmentaton in vitiligo in Mainland China, bringing novel treatment hopes for Chinese vitiligo patients.

CMS has always adhered to its mission of providing competitive products and services to meet unmet medical needs. Guided by innovation strategy, the Group continuously strengthens its independent R&D as well as external collaboration, enriching its product pipelines. Looking ahead, CMS will continue to identify products with differentiated advantages globally and efficiently promote their clinical development and commercialization, bringing more novel and effective drugs to patients.

About ruxolitinib cream

Ruxolitinib cream, (Opzelura), a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, and is the first and only treatment for repigmentation approved for use in the United States^[4]. Ruxolitinib cream (Opzelura) is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable^[5]. In Europe, ruxolitinib cream (Opzelura) is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age^[6].

The Product is not approved by the NMPA for any indication in Mainland China. However, on 12 August 2023, the Product was approved by Hainan Medical Products Administration for Urgent Clinical Import, and officially became available to applicable patients in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (the “Pilot Zone”) on August 18, for the topical treatment of non-segmental vitiligo in adults and adolescents aged 12 and above with facial involvement. Benefiting from the Early and Pilot Implementation Policy granted by the state to Hainan Free Trade Port and the Pilot Zone, patients with vitiligo in China can apply for the Product in Boao Super Hospital first and receive treatment from the expert team. In addition, ruxolitinib cream was approved by the Pharmaceutical Administration Bureau (ISAF) of Macau on 11 April 2024 for the topical treatment of non-segmental vitiligo with facial involvement in adult and adolescents form 12 years of age.

On 2 December 2022, the Group through a subsidiary of the Company, a dermatology medical aesthetic company (“CMS Skinhealth”) entered into a Collaboration and License Agreement (the “License Agreement”) with Incyte for topical formulations of ruxolitinib for the treatment of autoimmune and inflammatory dermatology diseases. In accordance with the  License Agreement, the Group through CMS Skinhealth received an exclusive license to develop, register and commercialize the Product in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, Taiwan Region and eleven Southeast Asian countries (Indonesia, Philippines, Vietnam, Thailand, Myanmar, Malaysia, Cambodia, Laos, Singapore, Timor-Leste and Brunei Darussalam) (the “Territory”) and a non-exclusive license to manufacture the Product in the Territory. The License Agreement commenced on its effective date and has a royalty term of ten years from the date of the commercial sale of the Product in the Territory (the “Royalty Term”). Upon the expiration of the Royalty Term, the License Agreement may be renewed for a period of ten years thereafter (the “Initial Extended Royalty Term”) as per certain conditions defined in the License Agreement. Upon the expiration of the Initial Extended Royalty Term, the License Agreement may be extended for a period otherwise agreed by both sides as per certain conditions defined in the License Agreement.

Incyte has worldwide rights for the development and commercialization of the Product, marketed in the United States and Europe as Opzelura®. Opzelura and the Opzelura logo are registered trademarks of Incyte.

About CMS

CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.

CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.

CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries. While strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology business, CMS independently operates its dermatology and medical aesthetics business, and ophthalmology business, aiming to gain leading positions in specialty therapeutic fields, whilst enhancing the scale and efficiency. At the same time, CMS has expanded its business territory to the Southeast Asian market, striving to become a “bridgehead” for global pharmaceutical companies to enter the Southeast Asian market, further escorting the sustainable and healthy development of the Group.

Reference：

1. Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015;386(9988):74-84. doi:10.1016/S0140-6736(14)60763-7
2. Consensus on the diagnosis and treatment of vitiligo (2021 version)
3. Kubelis-López DE, Zapata-Salazar NA, Said-Fernández SL, Sánchez-Domínguez CN, Salinas-Santander MA, Martínez-Rodríguez HG, Vázquez-Martínez OT, Wollina U, Lotti T, Ocampo-Candiani J. Updates and new medical treatments for vitiligo (Review). Exp Ther Med. 2021 Aug;22(2):797. doi: 10.3892/etm.2021.10229. Epub 2021 May 25. PMID: 34093753; PMCID: PMC8170669.
4. Drug approval information can be found on the FDA official website, as follows: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-topical-t…
5. Drug approval information can be found on the Incyte official website, as follows: https://investor.incyte.com/news-releases/news-release-details/incyte-an…
6. Drug approval information can be found on the EMA official website, as follows: https://www.ema.europa.eu/en/medicines/human/EPAR/opzelura

CMS Disclaimer and Forward-Looking Statements

This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.

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Source: China Medical System Holdings Ltd.